2 The technology

2 The technology

Ribociclib (Kisqali, Novartis)

Marketing authorisation

Ribociclib in combination with an aromatase inhibitor is indicated for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer as initial endocrine-based therapy.

Recommended dose and schedule

The recommended dose is 600 mg, taken orally, once daily for 21 consecutive days, followed by 7 days off treatment (28‑day cycle). Treatment should be continued as long as the patient is having clinical benefit from therapy or until unacceptable toxicity occurs.

Ribociclib should be used together with 2.5 mg letrozole or another aromatase inhibitor. The aromatase inhibitor is taken orally, once daily, continuously throughout the 28‑day cycle.

Some adverse reactions may need to be managed by temporary dose interruptions or delays, dose reductions, or permanently stopping the treatment.

See the summary of product characteristics for further details.

Price

£2,950 for a 63‑tablet pack of 200‑mg tablets (excluding VAT; MIMS online, accessed November 2017).

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of ribociclib, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)